Industry criticizes FDA's proposed DTC studies

Drugmakers questioned the methodology as well as the usefulness of some of the data the FDA is planning to collect for studies analyzing DTC advertising.

The FDA this year has announced a number of proposed studies meant to better understand consumer perceptions of DTC and how various tactics, such as using animated characters and the use of superimposed text, employed in those ads affect their perceptions.

The FDA has proposed studying the effect of animation, the use of superimposed text (text placed over an image), and how print drug ads — which make market claims, such as “#1 Prescribed” — impact the public's perception of the treatments advertised therein. The comment period for the animated study and superimposed text ended on May 9th and May 2nd, respectively. The agency is still accepting comments for its market claims study until June 3.

The National Advertising Coalition, a lobbying group, wrote that the FDA's proposal to study animations “must ensure that [its] regulations adhere to the First Amendment.” The First Amendment has become a common refrain for advertising lobbying groups defending advertising. In May, Amarin sued the FDA saying the regulator violated its First Amendment rights by limiting its ability to legally communicate benefits of its fish oil pill Vascepa. A court later ruled in Amarin's favor. Another drugmaker, Pacira Pharmaceuticals, sued the FDA saying that the agency's 2014 warning letter regarding its marketing of painkiller Exparel illegally narrowed its label. The FDA ultimately settled with Pacira, allowing the drugmaker to market Exparel beyond its original labeling.

The Coalition also cited Zauderer v. Office of Disciplinary Counsel, a case in which the Supreme Court ruled against the State of Ohio's argument that “pictures or illustrations in connection with advertising...may under some circumstances be deceptive or manipulative.”

AstraZeneca, too, offered its thoughts on the proposed animation study, offering feedback on some of the information the agency seeks to collect. The FDA has defined animated characters broadly. The agency includes any kind of animated characters that symbolize the disease, the benefit, the mode of administration, and the mechanism of action.

The drugmaker said that one question, which asked test takers to list how a drug ad made them feel, “could generate a testing bias that may affect the results,” Cheryl Jones, the drugmaker's associate director of promotional regulatory affairs, wrote in the comment letter. Jones added that deciding whether an ad is ethical “is not an appropriate metric for demonstrating the relative trust or lack thereof of in the ad.” The British drugmaker used animation techniques in its award-winning campaign, “Take it from a fish.”

The FDA's proposed study on market claims in print drug advertisements drew a number of comments from pharma companies.

Merck commented that the agency “should focus their efforts and research first on improving the health literacy of approved patient labeling and then on DTC advertising.” The FDA responded that efforts are underway to improve patient labeling and said it worked with a reviewer from the Office of Prescription Drug Promotion to produce efficacy claims that are “realistic.”

AbbVie also weighed in on the print study, calling out the FDA's use of the word “side effects,” which it thought could be interpreted as adverse effects or adverse events and “elicits a much more specific response than 'risks.'”

The agency responded to the drugmaker's concerns, saying “that consumers tend to think about risks and side effects together, which makes sense given the typical presentation of risks and side effects in direct-to-consumer promotional materials.”